CROSS-REFERENCE TO RELATED APPLICATIONThe present application is a continuation of U.S. application Ser. No. 12/117,973 filed May 9, 2008, which claims priority to provisional U.S. Application Ser. No. 60/917,423 filed May 11, 2007, to which Applicant claims the benefit of the earlier filing date. These applications are incorporated herein by reference and made a part hereof.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present invention relates generally to a clamp for use in plugging holes drilled in bone and, in particular, to a cranial clamp which is utilized to cover a burr hole drilled into a skull.
2. Description of the Related Art
In traditional neurosurgery, large sections of bone are removed from the skull. Once the procedure has been performed, there is a need to anchor the bone section back into place. Several mechanisms for achieving this function have been used, including small metallic plates affixed with screws or wires. Another mechanism has been a rigid cranial clamp which consists of two connected circular plates residing on the inside and outside surfaces of the skull.
More recently, neurosurgeons have been performing operations with a small drilled opening in the skull known as a burr hole. Such operations are less invasive than larger craniotomy procedures where larger sections of bone are removed. It is a goal of the neurosurgeon to plug the burr hole following such a procedure, typically utilizing a metallic circular plate affixed with multiple small screws as demonstrated in U.S. Pat. No. 5,578,036 to Stone et al. and U.S. Pat. No. 5,916,200 to Eppley et al.
Cranial clamps are considered superior to the metallic plates in that they are faster to place, do not involve additional drilling of screw holes into the skull, and do not require downward forces onto the skull with a screwdriver. Exemplary cranial clamps in the art include U.S. Pat. No. 6,685,707 to Roman et al., U.S. Pat. No. 6,379,363 to Herrington et al., and U.S. Pat. No. 6,068,631 to Lerch. While each of these cranial clamps are able to perform the intended function, they do not have the ability to be placed through a burr hole having a diameter smaller than the clamp itself. Such prior art clamps generally require additional devices to assist in placing the clamp in position, which further complicates the procedure.
Thus, it would be desirable for a clamp to be developed for use in plugging a burr hole formed in bone, and particularly a skull, which has the ability to be inserted through such burr hole. It would also be desirable for such clamp to be designed so that it is held rigidly in place without a threaded connection.
SUMMARY OF THE INVENTIONIn accordance with a first exemplary embodiment of the invention, a flexible clamp device for the anchoring of cranial bones is disclosed as including a plurality of flexible anchoring members and a stabilization member. Each of the plurality of flexible anchoring members includes an elongated body having an anchoring end and a second end opposite thereof, as well as a unidirectional ratcheting mechanism associated therewith. The flexible clamp device further includes a locking tab extending from the anchoring end of each elongated body adapted to clamp to an internal surface of a cranial bone, where the locking tab includes a first portion extending outwardly from the anchoring end of the elongated body and a second portion extending from the first locking tab portion toward the second end of the elongated body. A cross member is provided to connect the second ends of the elongated bodies, wherein the elongated body of each flexible anchoring member may be flexed such that the anchoring ends thereof are displaceable inwardly to facilitate placement through an aperture in a cranial bone.
The stabilization member further includes a plurality of pawl mechanisms to receive the unidirectional ratcheting mechanism on each elongated body, as well as a plurality of slits formed therein for receiving each elongated body. Accordingly, the stabilization member can be translocated from a first position adjacent the second ends of the elongated bodies to a second position adjacent the anchoring ends of the elongated bodies. The stabilization member in the second position constitutes a rigid clamp with the anchoring ends of the elongated bodies and causes such anchoring ends to be maintained in a spaced position. The stabilization member further includes a plurality of locking teeth extending from a lower surface thereof so as to engage an upper surface of the cranial bone.
In a second exemplary embodiment of the invention, a flexible clamp for plugging an aperture in a bone is disclosed as including: a plurality of flexible elongated bodies, where each elongated body has a first end and a second end opposite the first end; a locking tab connected to the first end of each elongated body; and, a stabilization member slidingly engagable with the elongated bodies, wherein the stabilization member may be translocated from a position adjacent the second ends of the elongated bodies to a clamping position adjacent the first ends of the elongated bodies. The locking tabs engage an inner surface of the bone and the stabilization member engages an outer surface of the bone when in the clamping position. The flexible clamp further includes a cross member connecting the second ends of the elongated bodies in spaced relation, a unilateral ratcheting mechanism associated with each elongated body, and a plurality of pawl mechanisms formed within the stabilization member which lockingly engage with each of the ratcheting mechanisms.
The stabilization member further comprises a substantially planar member slidingly engagable with the flexible elongated bodies and a plurality of locking teeth extending from a lower surface of the planar member in spaced relation which engage the outer surface of the bone when the stabilization member is in the clamping position. The planar member of the stabilization member further includes a plurality of slits formed partially therein for receiving the elongated bodies. The planar member may be any shape, but preferably is sized to cover the aperture in the bone.
The first ends of the elongated bodies are adjustably spaced or compressible when the stabilization member is positioned adjacent the second ends of the elongated bodies. The first ends of the elongated bodies are maintained in spaced relation when the stabilization member is positioned adjacent thereto. Accordingly, the position of the stabilization member along the elongated bodies controls the amount of movement available at the first ends of the elongated bodies. This permits the locking tabs of the elongated bodies to be movable between a position wider than the aperture to a position more narrow than the aperture.
In accordance with a third embodiment of the present invention, a method of positioning a clamp within an aperture in a cranial bone is disclosed, where the clamp includes a plurality of flexible elongated bodies and a stabilization member slidingly engagable therewith, comprising the following steps: maintaining second ends of the elongated bodies in a predetermined spaced position; flexing first ends of the elongated bodies from a predetermined spaced position wider than the aperture to a compressed position more narrow than the aperture; inserting the first ends of the elongated bodies through the aperture in the cranial bone; expanding the first ends of the elongated bodies from the compressed position to the predetermined spaced position so as to engage an inner surface of the cranial bone; and, translocating the stabilizing member from adjacent the second ends of the elongated bodies to a position adjacent the first ends thereof so as to engage an outer surface of the cranial bone. The method may further include the steps of locking the stabilizing member in the position, associating locking tabs with the first ends of the elongated bodies, engaging the stabilizing member with the elongated bodies, and trimming the elongated bodies after the stabilizing member engages the outer surface of the cranial bone. The stabilizing member may be engaged with the elongated bodies either prior to or after inserting the first ends of the elongated bodies through the aperture. The flexing step and translocation of the stabilizing member may be performed manually or with a clamping instrument.
In one aspect, one embodiment of the invention comprises a flexible clamp device for the anchoring of cranial bones, comprising a plurality of flexible anchoring members, and a stabilization member.
In another aspect, another embodiment of the invention comprises a method of placing a flexible cranial clamp, wherein the method comprises the steps of identifying a hole or other defect in a cranial bone, i.e. during neurosurgery, flexing of anchoring members of a flexible cranial clamp such that the anchoring members are displaced inward, placing inwardly-displaced locking members through the hole or other defect in cranial bone, and expanding and stabilizing the locking members by translocation of a sliding stabilization member towards the hole or other defect in cranial bone.
In still another aspect, another embodiment of the invention comprises a flexible clamp for plugging an aperture in a bone, comprising a plurality of flexible elongated bodies, each elongated body having a first end and a second end opposite the first end, a locking tab connected to the second end of each elongated body, and a stabilization member slidingly engagable with the elongated bodies, wherein the stabilization member may be translocated from a position adjacent the second ends of the elongated bodies to a clamping position adjacent the first ends of the elongated bodies, wherein each of the locking tabs engage an inner surface of the bone and the stabilization member engages an outer surface of the bone when in the clamping position.
In yet another aspect, another embodiment of the invention comprises a method of positioning a clamp within an aperture in a cranial bone, the clamp including a plurality of flexible elongated bodies and a stabilizing member slidingly engagable therewith, comprising the following steps maintaining second ends of the elongated bodies in a predetermined spaced position, flexing first ends of the elongated bodies from a predetermined spaced position wider than the aperture to a compressed position more narrow than the aperture, inserting the first ends of the elongated bodies through the aperture in the cranial bone, expanding the first ends of the elongated bodies from the compressed position to the predetermined spaced position so as to engage an inner surface of the cranial bone, and translocating the stabilizing member from adjacent the second ends of the elongated bodies to a position adjacent the first ends thereof so as to engage an outer surface of the cranial bone.
In still another aspect, another embodiment of the invention comprises a flexible clamp device for use with a cranial bone, comprising at least one flexible anchoring member for positioning on the cranial bone, and a stabilization member for slidably mounting on the at least one flexible anchoring member to cover a hole or opening in the cranial bone.
These and other objects and advantages of the invention will be apparent from the following description, the accompanying drawings and the appended claims.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGSFIG. 1 is a perspective view of a cranial clamp in accordance with the present invention, where the stabilizing member is located in a position midway between the first and second ends of the flexible anchoring members;
FIG. 2 is a perspective view of the cranial clamp depicted inFIG. 1, where the stabilizing member is in a position adjacent the first ends of the flexible anchoring members and the flexible anchoring members have been trimmed;
FIG. 3 is a side view of the cranial clamp depicted inFIG. 1, where the clamp is located above an aperture in a bone and the first ends of the flexible anchoring members are in an initial or spaced position;
FIG. 4 is a side view of the cranial clamp similar to that depicted inFIG. 3, where the stabilizing member is in a position adjacent the second ends of the flexible anchoring members and the first ends of the flexible anchoring members are brought together or compressed so as to permit insertion through the aperture in the bone;
FIG. 5 is a side view of the cranial clamp similar to that depicted inFIGS. 3 and 4, where the stabilizing member has been positioned adjacent the first ends of the flexible anchoring members so as to be engagingly positioned against an outer surface of the bone, the flexible arms have been expanded to their original spaced position, and the locking tabs associated with the first ends of the flexible anchoring members are engagingly positioned against an inner surface of the bone;
FIG. 6 is a side view of the cranial clamp similar to that depicted inFIG. 5, where the upper portions of the flexible anchoring members have been trimmed immediately above the stabilizing member;
FIG. 7 is a diagrammatic view of the cranial clamp depicted inFIG. 6 positioned with respect to a burr hole in a skull; and
FIG. 8 is a sectional view taken along the line8-8 inFIG. 3.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTSReferring now to the drawings in detail, wherein identical numerals indicate the same elements throughout the figures,FIG. 1 depicts aflexible clamp device10 which may be utilized for covering or plugging a burr hole or the like in a bone (e.g., a skull or cranium). It will be seen thatflexible clamp device10 preferably includes a plurality of flexible, elastic orresilient anchoring members12, each having a first or anchoringend14 and asecond end16 opposite thereof. As seen inFIG. 1, each flexible anchoringmember12 comprises an elongated body, substantially rectangular in shape, and has a relatively thin thickness so as to enable flexing. Across member18 is provided to integrally connect second ends16 offlexible anchoring members12. In this way, such second ends16 are maintained at a predetermined spacing. By contrast, first ends14 are not connected and therefore adjustable, elastic or flexible and moveable between a spaced position similar to that at second ends16 (FIG. 3) and a compressed position where such first ends14 are displaceable inwardly so as to be in close proximity (FIG. 4) to each other.
It will further be seen that each anchoringend14 comprises alocking tab20. The lockingtabs20, as shown, include a firstlocking tab portion22 extending outwardly from and substantially perpendicular tofirst end14, and a secondlocking tab portion24 that extends from firstlocking tab portion22 towardsecond end16 offlexible anchoring member12 as shown. It will be appreciated that firstlocking tab portions22 offlexible anchoring members12 may be sized to accommodate use offlexible clamp device10 with apertures of varying size incranial bone28. Secondlocking tab portion24 functions to contact aninner surface26 ofcranial bone28, as depicted inFIGS. 5 and 6, and may be oriented substantially perpendicular to firstlocking tab portion22 or at any preferred angle of engagement. While not shown, an edge orsurface30 of secondlocking tab portion24 may be tapered or extended to enhance engagement with cranial boneinner surface26.
Eachflexible anchoring member12 also preferably includes aratcheting mechanism32 positioned along anouter surface34 thereof.Such ratcheting mechanism32 generally will include a plurality of ratchets orteeth36 spaced along flexible anchoringmember12. For reasons discussed herein, it is preferred thatsuch teeth36 include a first surface38 (FIGS. 2 and 8) which is oriented so as to be angled or ramped in a direction towardfirst end14 offlexible anchoring member12 and asecond surface40 which is oriented substantially perpendicular toflexible anchoring member12. In this way, it will be seen that ratchetingmechanism32 is designed to permit movement therealong in one direction (i.e., unilaterally from second ends16 to first ends14), while preventing or restricting movement in an opposite direction.
Flexible clamp device10 further includes a stabilization member42 (FIG. 2) which slidingly receives theflexible anchoring members12 as shown. Accordingly,stabilization member42 is able to be translocated from a first position adjacent second ends16 of flexible anchoring members12 (seeFIGS. 3 and 4) to a second position adjacent first ends14 thereof (seeFIGS. 5,6 and7). It will be appreciated that first ends14 offlexible anchoring members12 will be able to be compressed or displaced inwardly whenstabilization member42 is located adjacent second ends16. Asstabilization member42 is translocated closer to first ends14 offlexible anchoring members12, however, the ability of first ends14 to be compressed decreases. Whenstabilization member42 is translocated to the point where it engages anouter surface44 ofcranial bone28, a rigid clamp is formed with lockingtabs20 and first ends14 offlexible anchoring members12 is maintained in a spaced position (seeFIG. 5).
More specifically, it will be seen thatstabilization member42 preferably includes a substantiallyplanar member46 that has a predetermined size and shape that may be useful for covering a particular aperture48 (FIG. 3) incranial bone28. An inventory ofplanar members46 may be interchangeable withflexible anchoring members12 to accommodate several sizes and shapes of apertures.
Further, a plurality ofslits50 are preferably formed inplanar member46 so as to permitstabilization member42 to receive and engageflexible anchoring members12. Whileplanar member46 may be slid laterally into position betweenadjacent teeth36 of ratchetingmechanisms32 to form the clamp with lockingtabs20, it is preferred that a plurality ofpawl members52 be formed inplanar member46 which are accessible viaslits50. This enablessuch pawl members52 to be aligned and engaged withteeth36 of ratchetingmechanisms32. In this way,stabilization member42 is able to be translocated unidirectionally until it is positioned adjacent to first ends14 offlexible anchoring members12 and forms a clamp with lockingtabs20. Of course, it will be understood thatpawl members52 are able to slide or ratchet overfirst surface38 ofratchet teeth36 in a direction toward first ends14 offlexible anchoring members12, whereassecond surface40 ofsuch ratchet teeth36 functions as a stop to prevent translocation ofstabilization member42 in a direction toward second ends16 offlexible anchoring members12.
A plurality of lockingteeth54 preferably extend from alower surface56 ofplanar member46 in order to better engageouter surface44 ofcranial bone28. Lockingteeth54 are preferably positioned intermittently around planar memberlower surface56 and may be sized and/or angled as desired.
With regard to the construction offlexible clamp device10, it is preferred that a pair offlexible anchoring members12 be formed and connected at second ends16 thereof by means of thecross member18. Lockingtabs20 are preferably formed at first ends14 offlexible anchoring members12, where first and secondlocking tab portions22 and24, respectively, may be formed, molded, machined, stamped or otherwise created. In addition, ratchetteeth36 may be created inflexible anchoring members12 by puncturing the walls thereof or otherwise attached thereto. Accordingly, this enables all such components to be a one-piece construction, which could simplify manufacturing offlexible clamp device10.
A method of positioning aflexible clamp device10 within anaperture48 of acranial bone28 is also provided by the present invention, whereflexible clamp device10 includes a plurality offlexible anchoring members12 and astabilization member42 slidingly engagable therewith. This method includes the following steps: maintaining second ends16 offlexible anchoring members12 in a predetermined spaced position; flexing first ends14 offlexible anchoring members12 from a predetermined spaced position wider thanaperture48 to a compressed position more narrow thanaperture48; inserting first ends14 offlexible anchoring members12 throughaperture48 incranial bone28; expanding first ends14 offlexible anchoring members12 away from each other from the compressed position to the predetermined spaced position so as to engage aninner surface26 ofcranial bone28; and, translocatingstabilization member42 from adjacent second ends16 offlexible anchoring members12 to a position adjacent first ends14 thereof so as to engage anouter surface44 ofcranial bone28. Oncestabilization member42 is in a clamping position adjacent first ends14, the method preferably includes the step of lockingstabilization member42 in position. Additional steps of the method preferably include associating lockingtabs20 with first ends14 offlexible anchoring members12 and trimmingflexible anchoring members12 afterstabilization member42 engagesouter surface44 ofcranial bone28 at a point immediately abovestabilization member42.
Further, the method generally will include the step of engagingstabilization member42 withflexible anchoring members12, such as by means ofslits50 as described herein. It will be appreciated thatstabilization member42 may be positioned in sliding engagement withflexible anchoring members12 either before or after first ends14 thereof are inserted throughaperture48.
Additionally, the flexing step of the method may be performed either manually or by means of a clamping instrument specially designed for the purpose. Likewise, translocation ofstabilization member42 according to the method may be performed either manually or via a clamping instrument.
Having shown and described the preferred embodiment of the present invention, further adaptations offlexible clamp device10,flexible anchoring members12,stabilization member42, and the other components thereof can be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the invention. Moreover, it will be understood that further adaptations of the method steps for positioning theflexible clamp device10 within anaperture48 of acranial bone28 may be accomplished by appropriate modifications by one of ordinary skill in the art.
Advantageously, theflexible clamp device10 provides many advantages, some of which include:
- a flexible clamp further comprising a cross member connecting the second ends of the elongated bodies in spaced relation;
- a flexible clamp further comprising a ratcheting mechanism associated with each elongated body, and a plurality of pawl mechanisms formed within the stabilization member which lockingly engage with each of the ratcheting mechanisms;
- a flexible clamp wherein the stabilization member further comprises a substantially planar member slidingly engagable with the elongated bodies, and plurality of locking teeth extending from a lower surface of the substantially planar member in spaced relation which engage the outer surface of the bone when the stabilization member is in the clamping position;
- a flexible clamp wherein the first ends of the elongated bodies are compressible when the stabilization member is positioned adjacent the second ends of the elongated bodies;
- a flexible clamp wherein the first ends of the elongated bodies are maintained in spaced relation when the stabilization member is positioned adjacent thereto;
- a flexible clamp wherein each of the ratcheting mechanisms associated with the elongated bodies are unidirectional;
- a flexible clamp wherein the locking tab further comprising a first portion extending outwardly from the first end of the elongated body, and a second portion extending from the first locking tab portion toward the second end of the elongated body;
- a flexible clamp wherein the second ends of the elongated bodies are spaced a predetermined amount;
- a flexible clamp wherein the first ends of the elongated bodies are adjustably spaced;
- a flexible clamp wherein the position of the stabilization member along the elongated bodies controls the amount of movement available at the first ends of the elongated bodies;
- a flexible clamp wherein the substantially planar member of the stabilization member further includes a plurality of slits formed partially therein for receiving the elongated bodies;
- a flexible clamp wherein the stabilization member is sized to be greater than a width of the aperture in the bone;
- a flexible clamp wherein the locking tabs of the elongated bodies are movable between a position wider than the aperture to a position more narrow than the aperture;
- a method of positioning a clamp within an aperture in a cranial bone further comprising the step of locking the stabilizing member in the position;
- a method of positioning a clamp within an aperture in a cranial bone further comprising the step of associating locking tabs with the first ends of the elongated bodies;
- a method of positioning a clamp within an aperture in a cranial bone further comprising the step of engaging the stabilizing member with the elongated bodies;
- a method of positioning a clamp within an aperture in a cranial bone wherein the stabilizing member is engaged with the elongated bodies prior to inserting the first ends of the elongated bodies through the aperture;
- a method of positioning a clamp within an aperture in a cranial bone wherein the stabilizing member is engaged with the elongated bodies after inserting the first ends of the elongated bodies through the aperture;
- a method of positioning a clamp within an aperture in a cranial bone wherein the flexing step is performed manually;
- a method of positioning a clamp within an aperture in a cranial bone wherein the flexing step is performed with a clamping instrument;
- a method of positioning a clamp within an aperture in a cranial bone wherein the translocation of the stabilizing member is performed manually;
- a method of positioning a clamp within an aperture in a cranial bone wherein the translocation of the stabilizing member is performed with a clamping instrument;
- a method of positioning a clamp within an aperture in a cranial bone further comprising the step of trimming the elongated bodies after the stabilizing member engages the outer surface of the cranial bone;
- a flexible clamp device wherein the at least one flexible anchoring member is an elongated body having an anchoring end and a second end opposite thereof;
- a flexible clamp device wherein the at least one flexible anchoring member comprises a unidirectional ratcheting mechanism;
- a flexible clamp device wherein the at least one flexible anchoring member comprises a locking tab extending from an anchoring end of the at least one flexible anchoring member and being adapted to clamp to an internal surface of a cranial bone;
- a flexible clamp device wherein the locking tab further comprises a first portion extending outwardly from the anchoring end of the at least one flexible anchoring member, and a second portion extending from the first locking tab portion toward a second end of the at least one flexible anchoring member;
- a flexible clamp device wherein the stabilization member further comprises a plurality of pawl mechanisms to receive the unidirectional ratcheting mechanism on each of the at least one flexible anchoring member; and
- a flexible clamp device wherein the stabilization member further comprises a plurality of slits formed therein for receiving each of the at least one flexible anchoring member.
While the method herein described, and the form of apparatus for carrying this method into effect, constitute preferred embodiments of this invention, it is to be understood that the invention is not limited to this precise method and form of apparatus, and that changes may be made in either without departing from the scope of the invention, which is defined in the appended claims.